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YY/T 0642-2022 English PDF

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YY/T 0642-2022: (Ultrasound - Sound field characteristics - Test methods for determining the thermal and mechanical indices of medical diagnostic ultrasound fields)
Status: Valid

YY/T 0642: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 0642-2022	English	1169	Add to Cart	7 days [Need to translate]	(Ultrasound - Sound field characteristics - Test methods for determining the thermal and mechanical indices of medical diagnostic ultrasound fields)	Valid	YY/T 0642-2022
YY/T 0642-2014	English	RFQ	ASK	3 days [Need to translate]	Ultrasonics. Field characterization. Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields	Obsolete	YY/T 0642-2014
YY/T 0642-2008	English	RFQ	ASK	4 days [Need to translate]	Ultrasonics. Field characterization. Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields	Obsolete	YY/T 0642-2008

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Basic data

Standard ID	YY/T 0642-2022 (YY/T0642-2022)
Description (Translated English)	(Ultrasound - Sound field characteristics - Test methods for determining the thermal and mechanical indices of medical diagnostic ultrasound fields)
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C41
Word Count Estimation	64,685
Issuing agency(ies)	State Drug Administration

YY/T 0642-2014: Ultrasonics. Field characterization. Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Ultrasonics.Field characterization.Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields ICS 17.140.50 C41 People's Republic of China pharmaceutical industry standards Replacing YY/T 0642-2008 Ultrasonic sound field characteristic to determine the medical diagnostic ultrasound Field test methods of thermal and mechanical indices (IEC 62359.2010, IDT) Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Preface Ⅰ Introduction Ⅱ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Symbol 13 5 Test methods to determine the mechanical index and thermal index of 15 Principle Appendix A (informative) Index model description and derivation of 21 Guidance Appendix B (informative) in composite mode, scan mode and 1cm × 1cm window, output power measurement 37 During Annex C (informative) ultrasonic irradiation, transducer self-heating temperature rise of the role of 43 Annex D (informative) Guidance on the interpretation of TI and MI 44 Annex E (informative) and IEC 62359 1st edition Differences 46 References 48

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard is identical with IEC 62359.2010 "ultrasonic sound field characteristic to determine the field of medical diagnostic ultrasound thermal and mechanical indices square test law". The IEC 62359 standard only made a very small amount of editorial changes. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee Technical Committee (SAC/TC10/SC2) Centralized. This standard was drafted. State Food and Drug Administration of Hubei Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Wang Zhijian, Jiang Shilin. This standard was first released in April 2008.

Introduction

Medical diagnostic imaging and ultrasound equipment in order to care for the purpose of clinical practice widely used. Working in a low frequency devices are often trillion Hz frequency range, the acoustic coupling of the patient with the ultrasound transducer and associated circuits. In current clinical practice, there are many Different types of systems. Ultrasound into the patient, with the patient's tissue interact, this interaction can be considered hot and non-thermal effects. The purpose of this standard Is a method for determining the thermal and non-thermal radiation of a predetermined index, these indices used to help assess the exposure of medical diagnostic and monitoring specific ultrasonic field of manufacturing Into danger. While these indicators have limitations in awareness of the clinical examination is not enough according to their index values to make a formal Clinical risk assessment. As scientific understanding of the depth of the standard expected subsequent amendments to address these limitations. In a further exploration At the same time, some organizations issued a statement with caution. Under certain conditions specified in GB 9706.9, for the above purpose, these indices show on medical ultrasound equipment. Ultrasonic sound field characteristic to determine the medical diagnostic ultrasound Field test methods of thermal and mechanical indices

1 Scope

This standard applies to medical diagnostic ultrasound field. This standard specifies. --- Diagnostic ultrasound field parameters related to thermal and non-thermal; --- Organization theory - equivalent model, the absorption caused by the ultrasonic method of determining the temperature rise associated with the radiation parameters; --- Suitable method for determining exposure parameters specific to the non-thermal effects. Note 1. In Chapter 3 of this standard, specific parameters are defined in the International System of Units (according to ISO /IEC Guide, Part 2, 5th Edition Appendix Ⅰb), for example, Beam area and intensity, in practice, it may use a decimal multiple or submultiple more convenient in use and calculated values, the user must Ten Binary prefixes and units combined. For example, you can use cm2 beam area as a unit, with the sound intensity W/cm2 or mW/cm2 units. Note 2. In the following calculations, the MI range from 0.25MHz ~ 15MHz, TI range from 0.5MHz ~ 15MHz. Note 3. Steady estimate heat index, based on compliance with "0.3dBcm-1MHz-1 attenuation model of homogeneous organization." [1] generated 1 ℃ temperature required for the organization Effective instantaneous acoustic output power, may not apply to radiation imaging or using a sufficiently long duration pulses or bursts and other similar technologies caused State temperature rise.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 7966-2009 of acoustic radiation force balance power measurement methods and performance requirements (IEC 61161.2006, IDT) GB 9706.9 Medical electrical equipment - Part 2-37. safety of ultrasonic medical diagnostic and monitoring equipment requirements (GB 9706.9- 2008, idtIEC 60601-2-37.2001) GB/T 20249-2006 Acoustics Definitions and measurement methods focused ultrasound transducer launch site characteristics (IEC 61828.2001, IDT) YY/T 0865-2011 Ultrasonic Hydrophones - Part 1. Measurement and features 40MHz describe the following medical ultrasound field (IEC 62127-1.2007) IEC 61157.2007 standard methods of medical diagnostic ultrasound equipment acoustic output released (Standardmeansforthereportingof theacousticoutputofmedicaldiagnosticultrasonicequipment) IEC 62127-2.2007 ultrasonic hydrophone Part 2. 40MHz or less ultrasound hydrophone calibration (Ultrasonics- Hydrophones-Part 2. Calibrationforultrasonicfieldsupto40MHz) IEC 62127-3.2007 - Part 3 ultrasonic hydrophone. 40MHz or less water ultrasound hydrophone characteristics (Ultrasonics- Hydrophones-Part 3. Propertiesofhydrophonesforultrasonicfieldsupto40MHz)

3 Terms and Definitions

GB/T 7966-2009, YY/T 0865-2011, IEC 61157.2008, IEC 62127-2.2007 and IEC 62127-3.2007 Defining the following terms and definitions apply to this document. Note. The definition of the unit, according to IEC /ISO Directives, Part 2, 5th Edition Appendix Ib), using the International System of Units. When using this standard, data sheets Bit different from the International System of Units, the user must be aware of the possible need for conversion units.

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